Tag:Regulation
DHS’s Partnership with Private Industries Leads to a Crackdown of Fraudulent Behavior During the Pandemic
After the COVID-19 pandemic spread to the U.S. in February of 2020, there was a surge in fraudulent behavior as criminals took advantage of the fear revolving around the pandemic to profit from selling defective goods and scamming the public. This has resulted in the loss of millions of dollars by the public. Scammers will continue to benefit and take advantage of the public until the government steps in and takes preventative measures to stop this criminal behavior during the pandemic.
CMS Issues New Rigid COVID-19 Requirements for Skilled Nursing Facilities
The Centers for Medicare & Medicaid Services (“CMS”) released new guidance for skilled nursing facilities (“SNFs”) as part of a larger rulemaking agenda for healthcare institutions in the throes of the current public health emergency with COVID-19. CMS has also detailed the fines for non-compliance with the new COVID-19 requirements for SNFs and other healthcare institutions such as hospitals and laboratories.
USPS and Delivering for America Act
On Saturday, August 22nd, the US House of Representatives voted on a new bill introduced, known as the Delivering for America Act. This legislation would prohibit the U.S. Postal Service (USPS) from making changes to operations or levels of service from those that were in effect on January 1, 2020. Specifically, the USPS may not, during the period beginning on enactment of the bill and ending on the last day of the COVID-19 (coronavirus disease 2019) public health emergency or January 1, 2021, whichever is later, implement or approve any change to the operations or the level of service that would impede prompt, reliable, and efficient services.
One Ballot, One Vote? Fears Amass Surrounding Mail-in Voting in 2020 Election
Mail-in voting has been in the forefront this election season due to persistent COVID-19 concerns. Tensions exist between those who claim that mail-in voting is a safe and valid alternative to in-person voting and those who argue that it will lead to widespread voter fraud and inaccurate election results. Illinois was recently front and center in this national discussion when a Facebook post went viral, asserting that an Illinois couple who received multiple ballot applications could submit them all and vote multiple times without anyone knowing. Far from true, such misconceptions have many questioning how states will monitor mail-in voting to ensure that it remains an effective option in this crucial election.
Financial Regulation During COVID-19
Coronavirus (COVID-19) has shaken the world economy, not the least of which the financial industry. As the financial industry has adapted to work-from-home life under the coronavirus pandemic, industry regulators such as the SEC and the Financial Industry Regulatory Authority (FINRA) have been forced to adapt rules to changing circumstances and shift their enforcement priorities to pandemic related fraud.
Standardization and Cooperation Needed to Fix Crumbling Infrastructure
Northeastern Michigan was already facing a pandemic on May 19 when a breach in the Edenville dam forced 10,000 residents to flee their homes in the face of deadly floodwater. The dam failure elevates the need for state and federal regulators to standardize regulations and collaborate on their enforcement to prevent similar incidents.
Corporate Cybersecurity: Managing Data in the Era of Cyberattacks
Within the last decade, data has surpassed oil as the world’s most valuable commodity. Earlier this year the Securities and Exchange Commission (SEC) released its observations made during audits that detailed the methods used by corporations to secure their data. This included the kinds of cybersecurity practices employed by companies as well as advice on how to better deal with sensitive data and protect against potential cyberattacks. The SEC’s observations coincide with a recent announcement from the National Security Agency (NSA) that showcases an increased concern surrounding cybersecurity in the corporate world.
Income Share Agreements; a Solution to Increasing Educational Debt in America or Just Another Student Loan?
In times of economic recession, Americans historically have sought additional education to mitigate minimal employment prospects and retrain for an evolving job market. Coding bootcamps may be especially attractive in the era of COVID as they provide vocational training in a growing field and many programs are offered remotely by design. These programs may become even more enticing because of a new financing instrument called an income share agreement (“ISA”).
Voting in the 2020 Election
Most United States citizens have certain expectations when they go to their polling station; voters expect to stand in a line, to be handed a ballot by an official, or to vote on a touch screen system. Yet, amid COVID-19, for many Americans, going to a polling station presents too many opportunities for the transmission of the virus. As a result of the danger of voting in-person and the desire to vote by mail, it is projected that the United States Postal Services (hereinafter “USPS”) will deliver an unprecedented number of mail-in ballots.
Pre-Approval Access and Pathways to Investigational Drugs
The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 requires pharmaceutical drugs to provide evidence of their safety before they are allowed on the market. As such, pharmaceutical companies submit applications to the Federal Drug Administration for approval. There are situations, however, in which patients seek to receive access to a particular pharmaceutical drug before the FDA approval process is complete. This blog will explore the various pathways to pre-approval access in addition to recent legislation and legal considerations for such pathways, in addition to the principles and common obstacles that pharmaceutical companies face within such pathways.